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Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

This 510(k) summary describes a medical device, Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), and its substantial equivalence to a predicate device. The document primarily focuses on demonstrating that the new device meets established ASTM standards and FDA requirements for patient examination gloves.

Here's an analysis of your requested information based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for testing each characteristic (e.g., number of gloves tested for pinholes, tensile strength). The data provenance is also not specified in terms of country of origin or whether the studies were retrospective or prospective. It only mentions that the subject device "meets" or "generated values" for the standards, implying that internal testing was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the provided document. The "ground truth" for this device's performance is based on established engineering standards (ASTM, ISO) and FDA regulations, rather than expert clinical judgment or consensus on specific cases. The tests are for objective physical and chemical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically associated with subjective assessments or diagnostic interpretations in clinical studies, not the objective measurement of physical properties of a glove.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to the provided document. An MRMC study with AI assistance is relevant for artificial intelligence or imaging devices, not for patient examination gloves.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a medical glove, not an algorithm or AI-powered system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on established objective technical standards and regulatory requirements. Specifically, this includes:

• ASTM D5250-06 (Reaffirmation 2011) for polyvinyl chloride examination gloves.
• ASTM D5151-06 (Reaffirmation 2011) for detection of holes in medical gloves.
• ASTM D6124-06 (Reaffirmation 2011) for residual powder on medical gloves.
• 21 CFR 800.20 for water leak test on pinhole AQL within FDA regulations.
• ISO 10993-10 Third Edition 2010-08-01 for biological evaluation of medical devices - irritation and skin sensitization.

The "ground truth" isn't an expert consensus on a subjective interpretation, but rather the defined acceptable parameters and test results dictated by these standards.

8. The sample size for the training set

This is not applicable. The device is a physical medical glove and does not involve any machine learning algorithms or training sets.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

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